Cadonilimab with chemotherapy followed by concurrent chemoradiotherapy for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares an induction and concurrent immunotherapy strategy — cadonilimab combined with chemotherapy followed by standard external-beam radiotherapy plus brachytherapy and concurrent chemotherapy — against the current standard of concurrent chemoradiotherapy alone. Eligible patients are adults with histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer at FIGO stage IIB–IVA and at least one measurable lesion by RECIST v1.1. The study tracks efficacy endpoints (tumor response, progression-free and overall survival) and safety outcomes throughout treatment and follow-up. Treatments are delivered at a single lead center with standardized radiotherapy and chemotherapy protocols.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be enrolled, subjects had to meet all of the following criteria:

1. Female, aged 18-70 years (inclusive of cutoff values);
2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
4. At least one measurable lesion according to RECIST v1.1;
5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
6. Have adequate organ function.

Exclusion Criteria:

Subjects were excluded from the study if they met any of the following criteria:

1. Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
2. He had undergone total hysterectomy (removal of the corpus uteri and cervix);
3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Guiling Li, PHD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Ting Liu, MD
• Email: clinicaltrials@akesobio.com
• Phone: +86 (0760) 8987 3999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.